Job offer from Thursday, May 23, 2019

Medical Device Software Engineer 80-100%

Kelly Scientific Resources KSR BaselBasel
  • Basel
  • Consultants
  • Temporary, 100%
  • Employee

Medical Device Software Engineer 80-100%

Our customer, a leading international pharmaceutical company with headquarters in Basel, is looking for an experienced
 
 
Medical Device Software Engineer 80-100%
 
In this exciting position you will support the development of Medical Devices by providing smart hardware, software, design control expertise and documentation support to a cross-functional teams including QA, Regulatory Affairs, Clinical, Commercial and IT functions.
 
 
Your responsibilities include:
 

  • Device technical engineering expert for the development of mobile and/or web applications classified as SaMD in close collaboration with internal and external software/IT teams
  • Providing software/systems life cycle expertise within a broader cross-functional SaMD development team
  • Draft and/or review and/or approve design control documents (i.e. DHF documents) to support SaMD development deliverables such as specifications, protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans/reports
  • Apply your sound knowledge of the regulatory landscape to ensure standard compliant SaMD implementation, working to Quality Management Systems such as ISO 13485, 21CFR820, risk management to ISO14971, ISO 62304
 
Your background:
 
You bring significant expertise in smart devices, medical software, software validation, design controls, risk management, quality system documentation, and technical knowledge to support the SaMD activities within our clients Device Development programs. Together with a university level education (engineering degree or related discipline) you bring a minimum 5 year proven track record in software development projects classified as SaMD preferable in the Pharmaceutical industry.
 
 
Assignment start: ASAP
Assignment duration: End of 2019 (prolongation possible)
Workplace: Basel
 
 
If you have the required experience and if you would like to apply for this interesting position, please send your complete application documents (CV, testimonials, diplomas) to diana.steinhauer(at)kellyservices.ch or apply online.
 
We are looking forward to getting to know you!
 

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